Summary:
Summary Statement of Deficiencies D0000 Based on a CLIA Reinstatement Survey performed on October 7, 2020, this facility was found to not be in compliance with all applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. D5427 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(c) (c) Documentation. The laboratory must document all activities specified in this section. This STANDARD is not met as evidenced by: Based on review of the BioRad D-10, A1c Analyzer (D-10) linearity studies, and staff review, the laboratory had performed the testing on the linearity specimens, but had not evaluated the linearity results for acceptability, and verification of results. Findings: 1. Review of the D-10 linearity performance documents, the laboratory had tested, evaluated, and documented the linearity performed on April 25, 2017. There were no other linearity documents to review. 2. Review of the data stored in the D-10, there was evidence that the linearity specimens had been ran, but not evaluated. 3. Staff interview with Testing Personnel, and Owner, on October 7, 2020, at approximately 1pm in the secondary lab room, confirmed that the linearity had been run, but had not been evaluated and signed by the Laboratory Director as acceptable. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --